ObesityNCT02977403
Mobile Attention Retraining in Overweight Female Adolescents
A study testing Attention Bias Retraining in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: People are constantly exposed to unhealthy foods. Some studies of adults show that training attention away from unhealthy foods might reduce overeating. Researchers want to see what happens in the brain when teens train their attention away from food through a program on a smartphone. Read more about this study
- Who is it for?
- Ages 12 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Binge Eating
- What is being tested?
- Attention Bias Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Volunteers will qualify if they meet the following criteria:
- Age between 12 and 17 years (at the start of the study).
- Female sex.
- BMI at or above the 85th percentile for age and sex according to the Centers for Disease Control US Standards (101).
- Right handedness.
- LOC sample only:
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- Greater than or equal to 1 episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.
- No-LOC sample only:
- No episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.
Who cannot join
- Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:
- An obesity-related health comorbidity requiring medical treatment, such as hypertension (defined by age-, sex-, and height-specific standards) or fasting hyperglycemia consistent with diabetes.
- Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Nonserious
- medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
- Regular use of any medication known to affect body weight or eating behavior (e.g., stimulants prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
- Current pregnancy or a history of pregnancy.
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- A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.
- Presence in the child of any significant, full-threshold psychiatric disorder based on DSM criteria (102), such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any other disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including subthreshold psychiatric disorders, will be permitted to enroll in the study. If, based on the opinion of the investigators, a participant requires treatment for his/her psychiatric symptoms, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will be excluded and be provided with treatment referrals.
- Current and regular substance use, including the use of alcohol and/or tobacco products (including e-cigarettes).
- A history of significant or recent brain injury that may considerably influence performance (i.e., any history of loss of consciousness greater than or equal to 30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or greater than or equal to 2 concussions within last year).
- Current involvement in a weight loss program, participating in psychotherapy aimed at weight loss or treatment of eating behavior (e.g., binge eating).
- All parents/guardians will be asked to indicate if their child has any food allergies. To be conservative, children who report allergies to gluten, nuts, dairy, fruit, or any other item in the array, will be excluded from the test meal portion of the study.
- A condition under which MEG is contradicted (e.g., metal in the body, pregnancy, claustrophobia, history of significant neurological insult or injury).
- Non-English speaking participants will be excluded from the study as they may be unable to complete questionnaires and follow the instructions which are only provided in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of Mobile Attention Training in Overweight Female Adolescents
Background:
People are constantly exposed to unhealthy foods. Some studies of adults show that training attention away from unhealthy foods might reduce overeating. Researchers want to see what happens in the brain when teens train their attention away from food through a program on a smartphone.
Read more
Objective:
To study the relationship between eating patterns, body weight, and how the brain reacts to different images.
Eligibility:
Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th percentile for age).
Design:
Participants will have 6 visits over about 8 months.
Visit 1: participants will be screened with:
Height, weight, blood pressure, and waist size measurements
Medical history
Physical exam
Urine sample
DXA scan. Participants will lie on a table while a very small dose of x-rays passes through the body.
Questions about their general health, social and psychological functioning, and eating habits
Parents or guardians of minor participants will answer questions about their child s functioning and demographic data.
Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will include some or all of these procedures:
Blood drawn
MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in a strong magnetic field. A device will be placed over the head.
Meals provided. Participants will fill out rating forms.
Simple thinking tasks
A cone containing magnetic field detectors placed onto the head
Medical history
Physical exam
Urine sample
Participants will be assigned to a 2-week smartphone program that involves looking at pictures. Participants will complete short tasks and answer some questions about their eating habits and mood on the smartphone.
Read the detailed description
Over 30% of adolescents are overweight and 20% are obese, but the mechanisms that produce excessive weight gain in youth remain incompletely elucidated. Some overweight youth appear to have an attention bias (AB: a tendency to attend selectively to stimuli that have acquired salience or meaning) toward highly palatable food that may lead to overeating. AB involves distinct cognitive processes, (1) unconscious reactions (UCR), reflecting initial attention capture evoked by salient stimuli, and (2) continued attention deployment (AD) to stimuli relevant to current goals. These rapidly evolving processes are associated with unique neurocircuitry best measured using high spatial resolution and temporal sensitivity. Magnetoencephalography (MEG) is a novel neuroimaging technology that has both excellent temporal and good spatial resolution, thus is uniquely and ideally suited to study neurocognitive mechanisms of AB. Reducing AB to palatable foods may help some overweight youth curb their consumption of energy-dense options. Attention retraining (AR) programs can be used to reduce AB and have been effective in reducing AB to unhealthy food in adults. Although most AR studies involve computers in the laboratory, using smartphones in the natural environment may be a particularly effective method to deliver AR to adolescents and measure AB using ecological momentary assessment. The first aim of the proposed study is to investigate, using MEG, the impact of a 2-week smartphone AR program on neural responses to food cues in overweight adolescent (12-17 y/o) girls with and without loss of control (LOC) eating, defined as a subjective experience of a lack of control over what or how much one is eating. LOC is a distinct eating behavior phenotype in youth that is a risk factor for excess weight gain and disordered eating, and is much more prevalent among girls (vs. boys). Overweight youth who report LOC may be particularly susceptible to AB. Additionally, adults with LOC demonstrate AB toward socially threatening cues, such as angry or disapproving faces, and the AB to social threat may be relevant to the relationship between AB to food and overweight. The second goal is to examine the effect of the 2-week AR program on AB, food intake, and body composition. An exploratory aim is to examine whether AB to socially threatening cues, moderates the effects of this novel intervention on AB to food cues, food intake, and body composition. The proposed study is innovative because no study to date has examined neurocircuitry of ABs to food using MEG, nor examined the impact of AR delivered in the natural environment on neurocircuitry of AB in a group of youth prone to AB. These studies may help further characterize phenomenology of distinct obesity subtypes and may potentially identify an approach that could prevent undue weight gain in adolescent girls at risk for obesity.
- Conditions
- Obesity, Overweight, Binge Eating, Healthy Volunteers
- Being tested
- Attention Bias Retraining, Sham Comparator: AB Control
- Keywords
- Binge Eating, Eating Behavior, Children, Magnetoencephalography, Loss of Control
- Medical subject headings
- Obesity, Overweight, Bulimia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias RetrainingBehavioural
Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
Sham Comparator: AB ControlBehavioural
Sham Comparator "training" where the probe randomly replaces the neutral or food pictures. There is no correlation between picture type and probe location
| Study group | Role | What they receive |
|---|---|---|
| AB Retraining | Experimental | Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location. Receives: Behavioral: Attention Bias Retraining |
| Control sham | Sham comparator | Sham Comparator program - the probe randomly replaces the neutral or food picture. There is no correlation between picture type and probe location Receives: Behavioral: Sham Comparator: AB Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time
AB was obtained for each stimulus pairing (High-Palatability Food [HPF] minus Non-Food [NF] image, Low-Palatability Food [LPF] minus NF image, HPF minus LPF image). Trials where the probe appeared behind the more food-salient cue (e.g., a HPF image, or LPF vs NF image) were considered congruent trials. Trials where the probe appeared behind the less salient cue (e.g., NF image, or LPF image when the other image was a HPF image) were considered incongruent trials. The average reaction time during incongruent trials was subtracted from reaction time during during congruent trials. Positive scores represent a quicker reaction time for (and bias towards) the more palatable stimulus, and negative scores represent a slower reaction time for (and bias away from) the more palatable stimulus. A difference score of 0 represents no bias towards or away from the more palatable stimulus. Only trials with correct responses for the direction of the probe were included in computations.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power at the caudate left hemisphere during attention capture (0-250ms following stimulus). Oscillatory power was normalized as per NeuroImage 39 (2008) pp 1788-1802, by estimating noise power as ρθ = WθTΣWθ (where Wθ is a (M × 1) column vector of weighting parameters that are tuned specifically to the location and orientation represented by θ, Σ represents the noise covariance matrix and ρθ is the beamformer-projected sensor noise power at the location and orientation θ). Within each stimuli-pairing and attention phase, oscillatory power during the incongruent trials was divided by oscillatory power during the congruent trials, then log transformed. Given a ratio was used, the oscillator power outcomes are unitless. Change in power (post-intervention minus pre-intervention) was calculated. Positive changes represent an increase in oscillatory power from pre- to post intervention.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere - During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Neural activity during a food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex right hemisphere during attention capture (0-250ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the the caudate left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis right hemisphere during attention deployment (250-500ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis left hemisphere during attention deployment (250-500ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Measured: 2-weeks
Secondary outcomes (1)
Frequency of Loss-of-control Eating Episodes
Frequency of self-reported loss-of-control eating episodes measured via the Eating Disorder Examination Interview at the baseline visit and post-EMA intervention visit (conducted 2 weeks after the baseline visit).
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start10 Feb 2017
- Primary completion8 Jun 2023
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Overweight youth with loss of control over eating randomized to intervention or control groups Overweight youth without loss of control over eating randomized to intervention or control groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977403
- Sponsor's protocol ID
- 170014
- Other IDs
- 17-CH-0014
- Status last verified
- May 2025
- First submitted
- 29 Nov 2016
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD that underlie results in a publication will be shared.
Publications
Shank LM, Tanofsky-Kraff M, Nelson EE, Shomaker LB, Ranzenhofer LM, Hannallah LM, Field SE, Vannucci A, Bongiorno DM, Brady SM, Condarco T, Demidowich A, Kelly NR, Cassidy O, Simmons WK, Engel SG, Pine DS, Yanovski JA. Attentional bias to food cues in youth with loss of control eating. Appetite. 2015 Apr;87:68-75. doi: 10.1016/j.appet.2014.11.027. Epub 2014 Nov 27.
PubMed 25435490Waters AM, Lipp OV, Spence SH. Attentional bias toward fear-related stimuli: an investigation with nonselected children and adults and children with anxiety disorders. J Exp Child Psychol. 2004 Dec;89(4):320-37. doi: 10.1016/j.jecp.2004.06.003.
PubMed 15560877Jarcho JM, Tanofsky-Kraff M, Nelson EE, Engel SG, Vannucci A, Field SE, Romer AL, Hannallah L, Brady SM, Demidowich AP, Shomaker LB, Courville AB, Pine DS, Yanovski JA. Neural activation during anticipated peer evaluation and laboratory meal intake in overweight girls with and without loss of control eating. Neuroimage. 2015 Mar;108:343-53. doi: 10.1016/j.neuroimage.2014.12.054. Epub 2014 Dec 27.
PubMed 25550068
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mobile Attention Training in Overweight Female Adolescents
- ClinicalTrials.gov ID
- NCT02977403
- Acronym / sponsor ID
- 170014
- Conditions
- Obesity, Overweight, Binge Eating, Healthy Volunteers
- Keywords
- Binge Eating, Eating Behavior, Children, Magnetoencephalography, Loss of Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People are constantly exposed to unhealthy foods. Some studies of adults show that training attention away from unhealthy foods might reduce overeating. Researchers want to see what happens in the brain when teens train their attention away from food through a program on a smartphone.
Objective:
To study the relationship between eating patterns, body weight, and how the brain reacts to different images.
Eligibility:
Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th percentile for age).
Design:
Participants will have 6 visits over about 8 months.
Visit 1: participants will be screened with:
Height, weight, blood pressure, and waist size measurements
Medical history
Physical exam
Urine sample
DXA scan. Participants will lie on a table while a very small dose of x-rays passes through the body.
Questions about their general health, social and psychological functioning, and eating habits
Parents or guardians of minor participants will answer questions about their child s functioning and demographic data.
Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will include some or all of these procedures:
Blood drawn
MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in a strong magnetic field. A device will be placed over the head.
Meals provided. Participants will fill out rating forms.
Simple thinking tasks
A cone containing magnetic field detectors placed onto the head
Medical history
Physical exam
Urine sample
Participants will be assigned to a 2-week smartphone program that involves looking at pictures. Participants will complete short tasks and answer some questions about their eating habits and mood on the smartphone.
Detailed description
Over 30% of adolescents are overweight and 20% are obese, but the mechanisms that produce excessive weight gain in youth remain incompletely elucidated. Some overweight youth appear to have an attention bias (AB: a tendency to attend selectively to stimuli that have acquired salience or meaning) toward highly palatable food that may lead to overeating. AB involves distinct cognitive processes, (1) unconscious reactions (UCR), reflecting initial attention capture evoked by salient stimuli, and (2) continued attention deployment (AD) to stimuli relevant to current goals. These rapidly evolving processes are associated with unique neurocircuitry best measured using high spatial resolution and temporal sensitivity. Magnetoencephalography (MEG) is a novel neuroimaging technology that has both excellent temporal and good spatial resolution, thus is uniquely and ideally suited to study neurocognitive mechanisms of AB. Reducing AB to palatable foods may help some overweight youth curb their consumption of energy-dense options. Attention retraining (AR) programs can be used to reduce AB and have been effective in reducing AB to unhealthy food in adults. Although most AR studies involve computers in the laboratory, using smartphones in the natural environment may be a particularly effective method to deliver AR to adolescents and measure AB using ecological momentary assessment. The first aim of the proposed study is to investigate, using MEG, the impact of a 2-week smartphone AR program on neural responses to food cues in overweight adolescent (12-17 y/o) girls with and without loss of control (LOC) eating, defined as a subjective experience of a lack of control over what or how much one is eating. LOC is a distinct eating behavior phenotype in youth that is a risk factor for excess weight gain and disordered eating, and is much more prevalent among girls (vs. boys). Overweight youth who report LOC may be particularly susceptible to AB. Additionally, adults with LOC demonstrate AB toward socially threatening cues, such as angry or disapproving faces, and the AB to social threat may be relevant to the relationship between AB to food and overweight. The second goal is to examine the effect of the 2-week AR program on AB, food intake, and body composition. An exploratory aim is to examine whether AB to socially threatening cues, moderates the effects of this novel intervention on AB to food cues, food intake, and body composition. The proposed study is innovative because no study to date has examined neurocircuitry of ABs to food using MEG, nor examined the impact of AR delivered in the natural environment on neurocircuitry of AB in a group of youth prone to AB. These studies may help further characterize phenomenology of distinct obesity subtypes and may potentially identify an approach that could prevent undue weight gain in adolescent girls at risk for obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Overweight youth with loss of control over eating randomized to intervention or control groups Overweight youth without loss of control over eating randomized to intervention or control groups
| Arm | Type | Receives |
|---|---|---|
| AB Retraining | Experimental | Behavioral: Attention Bias RetrainingActive treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location. |
| Control sham | Sham comparator | Behavioral: Sham Comparator: AB ControlSham Comparator program - the probe randomly replaces the neutral or food picture. There is no correlation between picture type and probe location |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age between 12 and 17 years (at the start of the study).
- Female sex.
- BMI at or above the 85th percentile for age and sex according to the Centers for Disease Control US Standards (101).
- Right handedness.
- Greater than or equal to 1 episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.
Key exclusion criteria (14 listed)
- Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:
- An obesity-related health comorbidity requiring medical treatment, such as hypertension (defined by age-, sex-, and height-specific standards) or fasting hyperglycemia consistent with diabetes.
- Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Nonserious
- medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
- Regular use of any medication known to affect body weight or eating behavior (e.g., stimulants prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Bias RetrainingAttention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location. | Behavioural | AB Retraining |
| Sham Comparator: AB ControlSham Comparator "training" where the probe randomly replaces the neutral or food pictures. There is no correlation between picture type and probe location | Behavioural | Control sham |
Primary outcome
Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time
Time frame: 2-weeks
AB was obtained for each stimulus pairing (High-Palatability Food [HPF] minus Non-Food [NF] image, Low-Palatability Food [LPF] minus NF image, HPF minus LPF image). Trials where the probe appeared behind the more food-salient cue (e.g., a HPF image, or LPF vs NF image) were considered congruent trials. Trials where the probe appeared behind the less salient cue (e.g., NF image, or LPF image when the other image was a HPF image) were considered incongruent trials. The average reaction time during incongruent trials was subtracted from reaction time during during congruent trials. Positive scores represent a quicker reaction time for (and bias towards) the more palatable stimulus, and negative scores represent a slower reaction time for (and bias away from) the more palatable stimulus. A difference score of 0 represents no bias towards or away from the more palatable stimulus. Only trials with correct responses for the direction of the probe were included in computations.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power at the caudate left hemisphere during attention capture (0-250ms following stimulus). Oscillatory power was normalized as per NeuroImage 39 (2008) pp 1788-1802, by estimating noise power as ρθ = WθTΣWθ (where Wθ is a (M × 1) column vector of weighting parameters that are tuned specifically to the location and orientation represented by θ, Σ represents the noise covariance matrix and ρθ is the beamformer-projected sensor noise power at the location and orientation θ). Within each stimuli-pairing and attention phase, oscillatory power during the incongruent trials was divided by oscillatory power during the congruent trials, then log transformed. Given a ratio was used, the oscillator power outcomes are unitless. Change in power (post-intervention minus pre-intervention) was calculated. Positive changes represent an increase in oscillatory power from pre- to post intervention.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere - During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Neural activity during a food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex right hemisphere during attention capture (0-250ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the the caudate left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis right hemisphere during attention deployment (250-500ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis left hemisphere during attention deployment (250-500ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
Time frame: 2-weeks
Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.
1 secondary outcome
Frequency of Loss-of-control Eating Episodes
Time frame: 2-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25435490Shank LM, Tanofsky-Kraff M, Nelson EE, Shomaker LB, Ranzenhofer LM, Hannallah LM, Field SE, Vannucci A, Bongiorno DM, Brady SM, Condarco T, Demidowich A, Kelly NR, Cassidy O, Simmons WK, Engel SG, Pine DS, Yanovski JA. Attentional bias to food cues in youth with loss of control eating. Appetite. 2015 Apr;87:68-75. doi: 10.1016/j.appet.2014.11.027. Epub 2014 Nov 27.
- Background: PubMed 15560877Waters AM, Lipp OV, Spence SH. Attentional bias toward fear-related stimuli: an investigation with nonselected children and adults and children with anxiety disorders. J Exp Child Psychol. 2004 Dec;89(4):320-37. doi: 10.1016/j.jecp.2004.06.003.
- Background: PubMed 25550068Jarcho JM, Tanofsky-Kraff M, Nelson EE, Engel SG, Vannucci A, Field SE, Romer AL, Hannallah L, Brady SM, Demidowich AP, Shomaker LB, Courville AB, Pine DS, Yanovski JA. Neural activation during anticipated peer evaluation and laboratory meal intake in overweight girls with and without loss of control eating. Neuroimage. 2015 Mar;108:343-53. doi: 10.1016/j.neuroimage.2014.12.054. Epub 2014 Dec 27.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Retraining in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time (time frame: 2-weeks). The study lists 53 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977403, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.